VP, Immunology & Rheumatology - Clinical Development

VP, Immunology & Rheumatology

• Clinical Development

Work Location

Corporate Headquarters (South San Francisco, CA) Onsite

• Hybrid

Non-local candidates will be considered

Position Summary

We are seeking an accomplished and visionary leader to join our team as VP, Immunology & Rheumatology

• Clinical Development. The VP, Immunology & Rheumatology

• Clinical Development will play a critical role in shaping and executing our Immunology strategy. In this role, the successful candidate will serve in a leadership role, helping set the direction of our efforts in classical complement-mediated autoimmune disease across the entire portfolio. In addition, the role will also be a member of the C1s Oral Small Molecule Core Team providing clinical and medical leadership in the overall strategy for that program, both in Phase 1 and Proof-of-Concept studies as well as later stages of development. Ultimately, the candidate would support the medical components of the submission, approval, and commercialization of drug candidates for the treatment of a range of autoimmune diseases. This role requires a seasoned professional with deep expertise in immunology and rheumatology as well as in drug development within this therapeutic area, possessing strong leadership skills and a track record of success in bringing innovative therapies to market. The VP, Immunology & Rheumatology

• Clinical Development will be responsible for driving the clinical strategic direction of our ANX1502 program working collaboratively with key team leadership. Like all Annexon leaders, the VP, Immunology & Rheumatology

• Clinical Development incumbent will have a deep-rooted commitment to serving patients and a passion for transforming the lives of people with serious diseases and their families.

Responsibilities

Drug Development:

• Lead the medical/clinical oversight of the Phase 1 and Proof-of-Concept studies including: review and interpretation of clinical data and communication with sites

• Medical authorship and ensuring the integrity and quality of abstracts, manuscripts, study reports, and regulatory communications and documents, and site or safety (in collaboration with pharmacovigilance) communications

• Identify core objectives that lead to the design and implementation of the clinical development strategy and protocols to support the clinical development of drug candidates

• Support other members of the team representing the Medical function including medical monitoring, trial execution, and safety and tolerability determination

• Represent Annexon and ANX007 program for external engagements with CRO's, consultants, sites, etc.

• In collaboration with Clinical Operations and Medical, oversee the execution of clinical trials, ensuring compliance with regulatory requirements, ethical standards, and timelines as well as support for all medical monitoring activities

• Serve as the Immunology and Rheumatology leader for the development team, partnering closely with the Program Team Leader, heads of development operations, clinical operations, pharmacovigilance, clinical quality, and biostatistics

• Provide medical leadership for site selection, feasibility, enrollment, issue identification/resolution, and data quality

• Support for business development activities in Immunology

Strategic Leadership:

• Serve as a member of the C1s Oral Small Molecule Core Team and Development Leadership Team to support the creation and execution of a strategic plan for ANX1502 and its follow-on molecules, in collaboration with team members, the Program Team Leader, Translational Medicine, Research and functional leadership

• Partner with the Research function in considering aspects of drug discovery that could be leveraged into development programs

• Leverage scientific and clinical expertise to guide decision-making and optimize study design and execution

• Leadership role in collaboration with Medical Affairs for KOL engagement, Advisory Committee interactions, and Steering Team meetings

• Drive innovation and differentiation of drug candidates through the deep and complete understanding of current and future data generated for the program

• In collaboration with Regulatory Affairs and ANX1502 Program team, develop and execute robust regulatory strategies for the program

• Interface with regulatory authorities to facilitate successful regulatory submissions and approvals.

• Stay abreast of evolving regulatory guidelines and requirements pertinent to immunologic drug development.

Cross-Functional Collaboration:

• Foster strong collaboration and alignment across functions, including R&D, clinical development, Translational Medicine, regulatory affairs, commercial, and other relevant departments.

• Serve as a key liaison between the Immunology team and executive leadership, providing regular updates on portfolio progress and strategic initiatives.

• Cultivate a culture of teamwork, innovation, and accountability within the ophthalmology organization.

Key Qualifications

• Advanced degree in medicine, or related field. Medical Degree with subspecialty training and practice in Immunology and Rheumatology strongly prefered

• Minimum of 15 years of experience in the pharmaceutical or biotechnology industry, with a focus on Immunology and Rheumatology drug development.

• Proven track record of leadership in Immunology, including successful development and commercialization of Immunologic or Rheumatologic products.

• In-depth understanding of immunologic diseases, drug development processes, and regulatory requirements.

• Demonstrated ability to develop and execute strategic plans, drive innovation, and deliver results in a fast-paced, dynamic environment.

• Strong leadership and interpersonal skills, with the ability to inspire and influence teams at all levels of the organization.

• Excellent communication and presentation skills, with the ability to effectively articulate complex scientific and clinical concepts to diverse audiences.

• Experience interacting with regulatory authorities and leading successful regulatory submissions and approvals.

• Business acumen and strategic thinking, with a focus on maximizing the commercial potential of ophthalmology products.

Company Summary

Annexon Biosciences (Nasdaq: ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Annexon's novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington's disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit annexonbio.com.

EEO Employer

• Annexon highly values Diversity, Equity, Inclusion and Belonging

Annexon Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment based on race, color, religion, national origin, age, gender, sex, ancestry, citizenship status, mental or physical disability, genetic information, sexual orientation, veteran status, or military status. We are proud to promote a work environment where everyone, from any background, can do their best work.

Staffing Agencies

Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn't have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon's website or Annexon Employees. Inquiries must be sent to talentacquisition@annexonbio.com with the Subject Heading: Staffing Agency Request.

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Annexon is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status.